Candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) and resource utilization and costs in Italy.

Chronic heart failure (HF) is a major cause of morbidity and mortality particularly in the elderly and a growing healthcare burden in Italy. The objective was to assess the cost-effectiveness of candesartan cilexetil, an angiotensin II type 1 receptor blocker (ARB) for the treatment of HF. A pre-specified economic evaluation was conducted on resource utilization (cardiovascular drug treatment, cardiovascular and non-cardiovascular hospital admission, cardiovascular procedures/operations) prospectively collected alongside the CHARM program, a series of parallel randomized clinical trials comparing candesartan with placebo (standard therapy) in patients with NYHA Class II-IV HF: CHARM-Alternative (LVEF < or =40% patients not receiving ACE inhibitors because of previous intolerance); CHARM-Added (LVEF < or =40% patients currently receiving ACE inhibitors); or CHARM-Preserved (LVEF > or =40% patients). The primary outcome for the component trials was the composite of cardiovascular death or worsening hospital admission for HF and of the overall program all-cause mortality. Adjunctive treatment with candesartan in CHARM-Alternative and CHARM-Added led to clinical benefits and to either cost-savings or a small additional cost, depending on the trial. The less certain clinical benefit in CHARM-Preserved was obtained at modest extra cost. The incremental cost-effectiveness ratios (ICERs) were estimated to range from euro713 per life year gained for CHARM-Alternative to dominant for CHARM-Added and the pooled reduced LVEF trials.